Catalog Number 300450 |
Device Problems
Detachment Of Device Component (1104); Structural Problem (2506)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 03/19/2018 |
Event Type
malfunction
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Manufacturer Narrative
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Date of event: unknown.The date received by manufacturer has been used for this field.Medical device expiration date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.The manufacturing location for this product is flextronics.This site is an oem manufacturing site.
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Event Description
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It was reported by the pharmacist that the bd¿ tray sharps¿ collector with funnel entry have had reported lids re-open after being sealed when they are accidentally knocked over.No reports of serious injury or medical intervention noted.
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Event Description
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It was reported by the pharmacist that the bd¿ tray sharps¿ collector with funnel entry have had reported lids re-open after being sealed when they are accidentally knocked over.No reports of serious injury or medical intervention noted.
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Manufacturer Narrative
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Correction: due to an it issue beginning on 7/3/2018, previously filed emdrs did not contain required fields.This supplemental emdr is filed to provide the following omitted fields: event attributed to: other.Device single use?: no.Device returned to manufacturer: no.
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Manufacturer Narrative
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Investigation summary: no photos or samples were received.A review of six dhrs was performed as part of this investigation; three dhr¿s before (6337926, 7034928, 7036919) and three after (7059925, 7075931, 7091903) of the lot number 7057963 reported under this complaint.The result did not reveal any issues during the manufacturing process.Additionally, ten samples from the current process were taken and assembled to rule out issues between the assembly of base and lid, during the evaluation no issues were found.Risk assessment (b)(4).According with this result a capa record should be open due to quantity of recurrences; however, the non-conformance can¿t be confirmed due to lack of evidence (samples/pictures).Based on information provided it was not possible determine the root cause like a failure mode related to the manufacturing process since there is no enough information like a picture or sample to confirm the non-conformance reported under this complaint.All the complaint information was captured for tracking and trending purposes, if additional information can be provided then a new complaint record will be open to perform a new investigation path.A corrective action is not required based on the results of the investigation.Trending for the reported issue will continue to be tracked and monitored.
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Event Description
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It was reported by the pharmacist that the bd¿ tray sharps¿ collector with funnel entry have had reported lids re-open after being sealed when they are accidentally knocked over.No reports of serious injury or medical intervention noted.
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Search Alerts/Recalls
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